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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 462 drug applications between 2 December 2025 and 8 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 102, covering 76 drug names.

2025/12/02 – 2025/12/08

Period
2025/12/02 to 2025/12/08, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
462
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
126

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

462filings, 102 of them generic

By application type

Application typeFilings
Supplement222
Generic102
New drug84
Import25
Import re-registration15
Unspecified14

By drug type

Drug typeFilings
Chemical drug263
TCM120
Therapeutic biologic63
Biologic10
In vitro diagnostic reagent4
Prophylactic biologic2

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Norepinephrine Bitartrate Injection539
2Riociguat Tablets314
3Metformin Hydrochloride And Empagliflozin Extended Release Tablets3112
4Mupirocin Ointment2230
5Tadalafil Tablets2123
6多种微量元素注射液(IV) · No verified English name214
7奥洛他定莫米松鼻喷雾剂 · No verified English name211
8左羟丙哌嗪糖浆 · No verified English name210
9恩曲替尼胶囊 · No verified English name216
10Lafutidine Tablets212

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

267 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fu Song Xian Zhong Yao Co., Ltd. romanized30300
2Eli Lilly and Company1210
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
4Ai Min Pharma Group Co., Ltd. romanized550
5Beijing Sai Er Bio Pharma Co., Ltd. romanized545
6Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized540
7Terumo Corporation Kofu Factory510
8Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized510
9Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized510
10Shanghai Ke Hua Bio Gong Cheng Co., Ltd. romanized440

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

143 this week

AcceptedDrugApplicants
2025/12/08Generic · Class 3 左羟丙哌嗪糖浆 · No verified English nameCYHS2504213 Hubei Wei Sen Pharmaceutical Co., Ltd. romanized
2025/12/08Generic · Class 3 左羟丙哌嗪糖浆 · No verified English nameCYHS2504212 Hubei Wei Sen Pharmaceutical Co., Ltd. romanized
2025/12/08Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2504211 Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2025/12/08New drug · Class 3.1 温经汤颗粒 · No verified English nameCXZS2500050 Shandong Run Zhong Pharma Co., Ltd. romanized
2025/12/08New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSL2501060 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/12/08New drug · Class 1 靶向BCMA的嵌合抗原受体T细胞注射液 · No verified English nameCXSL2501059 Shenzhen Pu Rui Jin Bio Pharma Co., Ltd. romanized
2025/12/08New drug · Class 3.3 重组抗CD38全人单克隆抗体注射液-皮下注射 · No verified English nameCXSL2501058 Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized; Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2025/12/08New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2501057 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/12/08New drug · Class 1 重组人源化抗HER2双特异性抗体注射液 · No verified English nameCXSL2501056 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2025/12/08New drug · Class 1 SYS6023 · No verified English nameCXSL2501055 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/12/08New drug · Class 1 MRG006A · No verified English nameCXSL2501054 Le Pu Bio Technology Co., Ltd. romanized
2025/12/08New drug · Class 1 DXC006 · No verified English nameCXSL2501053 Hangzhou Duo Xi Bio Technology Co., Ltd. romanized
2025/12/08New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2501052 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/12/08New drug · Class 1 HZ-A-018胶囊 · No verified English nameCXHL2501345 Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized
2025/12/08New drug · Class 1 HZ-A-018胶囊 · No verified English nameCXHL2501344 Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized
2025/12/08New drug · Class 2.4 注射用西罗莫司(白蛋白结合型) · No verified English nameCXHL2501343 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2025/12/06Generic · Class 3 Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHS2504210 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2025/12/06Generic · Class 3 多种微量元素注射液(IV) · No verified English nameCYHS2504209 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; CISEN PHARMACEUTICAL CO., LTD.
2025/12/06Generic · Class 3 多种微量元素注射液(IV) · No verified English nameCYHS2504207 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; CISEN PHARMACEUTICAL CO., LTD.
2025/12/06Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2504204 Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2025/12/06Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2504203 Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2025/12/06Generic · Class 3 依巴斯汀口崩片 · No verified English nameCYHS2504202 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2025/12/06Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2504199 Shenzhen Da Fu Pharma Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2025/12/06Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2504197 Hubei Wu Shi Pharma Co., Ltd. romanized
2025/12/06Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2504196 Hubei Wu Shi Pharma Co., Ltd. romanized
2025/12/06Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2504195 Hubei Wu Shi Pharma Co., Ltd. romanized
2025/12/06New drug · Class 3.1 清金化痰颗粒 · No verified English nameCXZS2500049 Shandong Feng Huang Pharmaceutical Co., Ltd. romanized
2025/12/06New drug · Class 1.1 九味儿感颗粒 · No verified English nameCXZL2500125 Chongqing Shi Zhong Yao Research Institute (Chongqing Shi Zhong Yao Bo Wu Guan) romanized; Sichuan Sheng Zhong Pharmaceuticals Ke College (Sichuan Sheng Zhong Yao Research Institute) romanized
2025/12/06New drug · Class 2 乙型肝炎病毒表面抗原诊断试剂盒(化学发光法) · No verified English nameCXSS2500135 Shanghai Ke Hua Bio Gong Cheng Co., Ltd. romanized
2025/12/06New drug · Class 3.3 冻干人用狂犬病疫苗(2BS细胞) · No verified English nameCXSS2500134 Chengdu Bio Zhi Pin Research Institute Co., Ltd. romanized

113 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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